ANDA 078288

BAXTER HLTHCARE CORP

FDA Drug Application

Application #078288

Application Sponsors

ANDA 078288

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2013-02-22
LABELING; Labeling	SUPPL	2	AP	2014-12-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-12-08	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	3	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78288
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)